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FDA Recalls
›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 321–340 of 786 recalls

Class IIITerminated

is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the phospholipid cardiolipin in human serum and EDTA, lithium heparin or citrated plasma. It is intended to assess anti-cardiolipin IgM autoantibody levels in patients where this information is useful in diagnosis, particularly in the assessment of thrombotic risk in patients with systemic lupus erythematosus, or other lupus-like disorders.

Euro Diagnostica AB

Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.

October 21, 2016 · DeviceView details →

Class IIITerminated

OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigation System with iBlock (Now OMNIBotics) is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for: Total Knee Arthroplasty

OMNI LIFE SCIENCE

Incorrect lot number on outer kit

October 14, 2016 · DeviceView details →

Class IIITerminated

Brilliance iCT Computed Tomography X-ray system, Model 728306

Philips Medical Systems (Cleveland) Inc

The product label does not include the correct current rating.

October 13, 2016 · DeviceView details →

Class IIITerminated

Ingenuity Core Computed Tomography X-ray system, Model 728321

Philips Medical Systems (Cleveland) Inc

The product label does not include the correct current rating.

October 13, 2016 · DeviceView details →

Class IIITerminated

Brilliance ICT SP Computed Tomography X-ray system, Model 728311

Philips Medical Systems (Cleveland) Inc

The product label does not include the correct current rating.

October 13, 2016 · DeviceView details →

Class IIITerminated

IQon Spectral CT Computed Tomography X-ray system, Model 728332

Philips Medical Systems (Cleveland) Inc

The product label does not include the correct current rating.

October 13, 2016 · DeviceView details →

Class IIITerminated

Ingenuity Core 128 Computed Tomography X-ray system, Model 728323

Philips Medical Systems (Cleveland) Inc

The product label does not include the correct current rating.

October 13, 2016 · DeviceView details →

Class IIITerminated

Ingenuity CT Computed Tomography X-ray system, Model 728326

Philips Medical Systems (Cleveland) Inc

The product label does not include the correct current rating.

October 13, 2016 · DeviceView details →

Class IIITerminated

RF MultiGen¿, 0406-900-000; Refurb RF MultiGen¿, 0406-900-000U

Stryker Instruments Div. of Stryker Corporation

Stryker Instruments is voluntarily recalling the Care Instructions/Instructions for Use packaged with the Radiofrequency (RF) MultiGen¿ Generator, because the instructions for use incorrectly contained instructions supporting the sterilization of the MultiGen¿ cables.

October 11, 2016 · DeviceView details →

Class IIITerminated

ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T NON-ECHO S PG, Item Number H787065970655, Catalog No.REF 06597065, 2) 4 F Stiffened Micro-Introducer Kit, STF 4F M.I. KIT 45CM NT/T NON-ECHO S PG, Item Number H787065970695, Catalog No.REF 06597069 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick

Angiodynamics, Inc.

Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub during use. AngioDynamics has confirmed that affected sheath/dilators (Greatbatch Model Numbers 10904-001 and 10904-002) have been included in packaged AngioDynamics Stiffened Micro-Introducer Kits.

September 28, 2016 · DeviceView details →

Class IIITerminated

ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T ECHO B PG, Item Number H787065970465, Catalog No.REF 06597046, 2) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T ECHO S PG, Item Number H787065970485, Catalog No. REF 06597048 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick

Angiodynamics, Inc.

Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub during use. AngioDynamics has confirmed that affected sheath/dilators (Greatbatch Model Numbers 10904-001 and 10904-002) have been included in packaged AngioDynamics Stiffened Micro-Introducer Kits.

September 28, 2016 · DeviceView details →

Class IIITerminated

ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM SS/SS ECHO B PG, Item Number H787065970395, Catalog No.REF 06597039, 2) 5 F Stiffened Micro-Introducer Kit, STF 5F M.I. KIT 45CM SS/SS ECHO S PG, Item Number H787065970415, Catalog No. REF 06597041 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick

Angiodynamics, Inc.

Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub during use. AngioDynamics has confirmed that affected sheath/dilators (Greatbatch Model Numbers 10904-001 and 10904-002) have been included in packaged AngioDynamics Stiffened Micro-Introducer Kits.

September 28, 2016 · DeviceView details →

Class IIITerminated

ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, Item Number H787065970515, Catalog No.REF 06597051, 2) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO S PG, Item Number H787065970535, Catalog No.REF 06597053, 3) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO A PG, Item Number H787065970555, Catalog No.REF 06597055 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick

Angiodynamics, Inc.

Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub during use. AngioDynamics has confirmed that affected sheath/dilators (Greatbatch Model Numbers 10904-001 and 10904-002) have been included in packaged AngioDynamics Stiffened Micro-Introducer Kits.

September 28, 2016 · DeviceView details →

Class IIITerminated

ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, Item Number H787065970505, Catalog No.REF 06597050, 2) 4 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO S PG, Item Number H787065970525, Catalog No.REF 06597052, 3) 4 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO A PG, Item Number H787065970545, Catalog No.REF 06597054 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick

Angiodynamics, Inc.

Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub during use. AngioDynamics has confirmed that affected sheath/dilators (Greatbatch Model Numbers 10904-001 and 10904-002) have been included in packaged AngioDynamics Stiffened Micro-Introducer Kits.

September 28, 2016 · DeviceView details →

Class IIITerminated

ANGIODYNAMICS 4F Stiffened Micro-Introducer, Item Number H787065971035, Catalog No.REF 06597103 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick

Angiodynamics, Inc.

Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub during use. AngioDynamics has confirmed that affected sheath/dilators (Greatbatch Model Numbers 10904-001 and 10904-002) have been included in packaged AngioDynamics Stiffened Micro-Introducer Kits.

September 28, 2016 · DeviceView details →

Class IIITerminated

Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiation of microorganisms on the basis of urease production

Acumedia Manufacturers, Inc.

Storage temperature listed on the label was incorrect. Label stated 2-30¿C. Actual storage temperature is 2-8¿C.

September 25, 2016 · DeviceView details →

Class IIITerminated

Siemens RAPIDPoint 400 Measurement Cartridge Siemens SMN numbers:10329756, 10341161

Siemens Healthcare Diagnostics Inc

Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measurement Cartridge

September 2, 2016 · DeviceView details →

Class IIITerminated

Siemens RAPIDPoint 405 Measurement Cartridge Siemens SMN numbers: 10844812, 1028322, 10313971 , 10310469

Siemens Healthcare Diagnostics Inc

Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measurement Cartridge

September 2, 2016 · DeviceView details →

Class IIITerminated

Dimension Vista IRON Flex reagent cartridges

Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and Dimension Vista IRON assays at a different concentration than listed in the Instructions for Use (IFU).

August 25, 2016 · DeviceView details →

Class IIITerminated

Dimension IRON Flex reagent cartridges

Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and Dimension Vista IRON assays at a different concentration than listed in the Instructions for Use (IFU).

August 25, 2016 · DeviceView details →

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